NCT03291990

5 Fraction Stereotactic Radiosurgery With Temozolomide for Glioblastoma Multiforme

A Pilot Study to Assess Feasibility of 5 Fraction Hypofractionated Stereotactic Radiosurgery Along With Standard Temozolomide as a Lymphocyte Sparing Therapy for Glioblastoma Multiforme

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This investigation is not only to develop an improved radiation/temozolomide approach, but also develop a regimen with potential to form the basis of better combined therapy with immune based treatments.

Detailed description

Glioblastoma has a poor prognosis with median survival is 14-16 months for patients enrolling in clinical trials, and across the United States one year survival is reported in the Surveillance, Epidemiology, and End Results (SEER) registry to be only 35%. Radiation treatment related lymphopenia has been associated with poor tumor outcome in Glioblastoma and a variety of other tumor types. As this lymphopenias is prolonged, it may also reduce efficacy of the checkpoint inhibitor lymphocyte mediated immune therapies now approved by the FDA for an increasing number of indications. Modeling and clinical studies suggest that administering radiation over 5 or fewer days (rather than standard 30 days of treatment) may reduce the incidence of lymphopenia.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	Temozolomide	5 fraction hypofractionated stereotactic radiosurgery along with standard temozolomide

Timeline

• Start date: 2017-10-18
• Primary completion: 2020-08-19
• Completion: 2020-08-19
• First posted: 2017-09-25
• Last updated: 2021-11-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study